K973850 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007. This device is classified as a Recorder, Pressure, Intrauterine (Class II - Special Controls, product code HFO).
Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on November 12, 1997, 35 days after receiving the submission on October 8, 1997.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2700.
| 510(k) Number | K973850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 1997 |
| Decision Date | November 12, 1997 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFO — Recorder, Pressure, Intrauterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2700 |